Post Traumatic Stress DisorderNCT05374408
Using Mobile Technology to Address the Trauma Mental Health Treatment Gap
An observational study of Post Traumatic Stress Disorder, run by University of Nebraska at 2 sites in United States.
Trial summary
BounceBack Now (BBN) is a self-help, trauma-focused mental health mobile application (app) with automated assessment with treatment guidance and in-app evidence-based treatment support for depression, post-traumatic stress disorder (PTSD), sleep difficulties, and anxiety. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Aim 2: BounceBack Now (BBN) for Trauma Informed Care Deployment, Aim 1 Participant Focus Groups and Aim 1 BHP Focus Groups
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Aug 2022to 22 Mar 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with a trauma related disorder and behavioral health providers (BHPs) which are Clinical staff, providers and administration
Who may be able to join
- Behavioral Health Providers:
- 19 years and older
- Participants:
- 19 years and older
- Newly referred to a behavioral health provider at the Fontanelle or Midtown Clinic
- Own a smart phone
Who cannot join
- Behavioral Health Providers:
- 18 years and younger
- Participants:
- 18 years and younger
- Referred to a behavioral health provider in the past year
- Does not own a smart phone
Show all 9Show fewer
- Score 2 points or lower on the Adverse Childhood Experience screening
- High suicidality based on a clinical assessment by the behavioral health provider
- Having neurocognitive conditions either assessed by a primary care provider or diagnostic code for neurocognitive condition found in the patient note or Electronic Health Record (EHR)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Nebraska Medical Center-Fontenelle Clinic
Omaha, Nebraska, 68104
Nebraska Medical Center-Midtown Clinic
Omaha, Nebraska, 68131
About this study
Official title: IDeA-CTR-Using Mobile Technology to Address the Trauma Mental Health Treatment Gap in Primary Care: Developing Implementation Protocols for Primary Care
BounceBack Now (BBN) is a self-help, trauma-focused mental health mobile application (app) with automated assessment with treatment guidance and in-app evidence-based treatment support for depression, post-traumatic stress disorder (PTSD), sleep difficulties, and anxiety. BBN contains many of the necessary components to promote self-management of these conditions. Investigators will evaluate the app's feasibility and acceptability among under served participants (e.g., African Americans and participants with lower socioeconomic status) with trauma histories in an integrated primary care (IPC) setting. There are two specific aims: 1) to develop educational materials for patients and behavioral health providers for BBN in IPC, and 2) to conduct a pilot trial of BBN for participants with trauma histories in an IPC setting. For Aim 1, focus groups with behavioral health providers and participants will be conducted to obtain feedback about BBN and training materials. For Aim 2, a feasibility study with 15 participants will be conducted to identify and address any procedural issues and to refine the protocol before conducting the full-scale study.
Read the detailed description
BounceBack Now (BBN) is a Trauma Focused Mobile Application. After consent, a behavioral health provider (BHP) will assist the participant in downloading BBN onto their smartphone device. The current BBN structure contains a brief assessment and multiple treatment components for disorders that are frequently associated with traumatic event exposure. A brief assessment based on the Kessler 6 will be completed and based on this assessment, the participants are then guided to treatment recommendations with an interactive rationale for each treatment. Education/explanations are provided in written, spoken, and animated video formats. Given that each of these treatments may be beneficial for patients with subsyndromal or very minor symptoms, all participants are able to see and interact with all treatment components, but it is anticipated that BHPs will provide recommendations for the sections that will be most beneficial. The treatment components are each based on effective in-person interventions. These include behavioral activation (depression), Written Exposure Therapy, and Expressive Writing (PTSD), Cognitive Behavioral Therapy for Sleep, and Relaxation/Mindfulness (stress/anxiety). The corresponding app sections are titled Activate, Write, Sleep, and Coping Tools, respectively. Each of these sections contains education components and there is a separate education component for the app overall that can be found through the coping tools page.
Aim 1: Develop educational materials for patients and Behavioral Health Providers (BHPs) for BBN in integrated primary care (IPC) settings. Investigators will present the educational materials and BBN in focus groups. These focus groups may be conducted virtually (i.e., zoom call) or in-person. The focus group will last 30 - 60 minutes. Focus groups will address acceptability, feasibility, and usability of the materials and the education materials and the app.
Focus groups will be audio recorded and a transcript will be prepared. Information obtained from the focus groups will be used to refine the patient and provider educational materials before we implement Aim 2 activities.
Aim 2: Conduct a pilot trial of BBN for participants with trauma histories in an IPC setting. A primary care provider at one of the two approved clinic locations will do a standard "warm handoff" referral to a behavioral health provider (BHP) if the patient is determined to have a behavioral health issue. The BHP will ask the patient about interest in participating the app study. If so, informed consent will be obtained and the participant screened using the Adverse Childhood Experience (ACE) screener to identify individuals at risk for trauma related conditions. Participants who screen positive on the ACE (>=3 points) will be invited to participate in further data collection for the study. A clinical assessment will be conducted, and a treatment assigned according to the standard of care specific to the mental health conditions of the participant. A brief explanation of BBN will be provided using the patient education material created under Aim 1. Certain features of the app will be suggested for use (e.g., journal, sleep intervention) according to participant need. The application is entirely self-paced, but a minimum use at least once a week is recommended.
Participants will complete a baseline survey online or through an investigational team member. Participants will continue to meet with their BHP as determined by the standard of care interactions, and, if deemed appropriate the BHP will highlight features contained in BBN for participant to use in between appointments. Follow-up phone calls will be scheduled for 2 week and 6 weeks after the initial visit to complete follow-up surveys, either online or administered by the investigative assistant over the phone. At the 6-week follow-up phone call, usability of the app will be assessed using the 18-item mHealth App Usability Questionnaire (MAUQ). Acceptability will be measured using the 20-item User Burden Scale. Additionally semi-structured interviews will be completed at that time or scheduled for an alternate date. The BHPs will complete a 5-item questionnaire about their comfort-level with integrating mental health apps into clinic care.
Addressing Needs of African American and Low-Income Patients:
The participating clinics primarily serve African American or low income patients. Race/ethnicity and income information will be collected through electronic health record data. The needs of these two patient population groups will be met by recruiting participants primarily from these two population groups for both aims to ensure their perspectives will be reflected in the patient education materials and by obtaining feedback through the individual interviews conducted at the end of the study.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Aim 2: BounceBack Now (BBN) for Trauma Informed Care Deployment, Aim 1 Participant Focus Groups, Aim 1 BHP Focus Groups, Aim 2: BHP, Provider, Staff and Admin Focus Groups, Aim 2 : Participant Focus Group
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aim 2: BounceBack Now (BBN) for Trauma Informed Care DeploymentBehavioural
Brief explanation of BounceBack Now (BBN) will be provided. Participants will be directed to areas of the application that are congruent with treatment focus identified during their standard of care appointment.
Participants will complete a baseline survey by either going online or being contacted by a member of the investigational team. The investigative assistant will contact all participants in 2-3 days to help the participant navigate the BBN and complete the baseline survey, if needed.
The participant will continue to meet with their behavioral health provider (BHP) as determined by the standard of care interactions. BHP will highlight features contained in BBN for participant to use in between appointments.
Follow-up phone calls will be scheduled for 2 weeks and 6 weeks after initial visit. During these phone- calls the participant will be contacted by a member of the investigational team to complete follow-up surveys.
Aim 1 Participant Focus GroupsBehavioural
At the beginning of the focus group the patients will be asked to download BBN on their smartphone device with the assistance of the research team, if they have not already done so. A basic tutorial of the BBN and the developed educational materials will be conducted/reviewed with the participants.
After the tutorial and education has been provided the participants will be asked to try some of major features of the app. Then, they will be asked to review the patient education materials. They will be asked to discuss strengths and weaknesses of the materials. They will be also asked whether there is any content missing from the education material.
Aim 1 BHP Focus GroupsBehavioural
At the beginning of the focus group the BHPs will be asked to download BBN on their smartphone device with the assistance of the research team, if they have not already done so. A basic tutorial of the BBN and the developed educational materials will be conducted/reviewed with the BHPs.
After the tutorial and education has been provided the participants will be asked to try some of major features of the app. Then, they will be asked to review the patient education materials. They will be asked to discuss strengths and weaknesses of the materials. They will be also asked whether there is any content missing from the education material.
Aim 2: BHP, Provider, Staff and Admin Focus GroupsBehavioural
Semi-structured interviews will be conducted with BHPs, Clinical Staff, Providers and Administration They will ask questions to BHPs, Clinical Staff, Providers and Administration about feasibility, acceptability, and usability of BBN and overall clinical protocol.
Aim 2 : Participant Focus GroupBehavioural
Semi-structured interviews will be conducted with Participants to assess the feasibility, acceptability, and usability of BBN.
| Study group | Role | What they receive |
|---|---|---|
| BounceBack Now (BBN) Participants Aim 1 | Participants who are receiving care at one of the designated integrated care clinics. Receives: Behavioral: Aim 1 Participant Focus Groups | |
| BounceBack Now (BBN) Behavioral Health Provider Aim 1 | Behavioral Health Providers who serve as a BHP at one of the designated integrated care clinics. Receives: Behavioral: Aim 1 BHP Focus Groups | |
| BounceBack Now (BBN) Participants Aim 2 | Participants who are receiving care at a designated integrated care clinic Receives: Behavioral: Aim 2: BounceBack Now (BBN) for Trauma Informed Care Deployment; Behavioral: Aim 2 : Participant Focus Group | |
| Bounce Back Now (BBN) Aim 2 BHPs, Clinical Staff, Providers, and Administration | Clinical staff, Behavioral Health Providers, Providers, and Administration staff who can provide feedback pertaining to the factors that contribute to app deployment in an integrated care setting. Receives: Behavioral: Aim 2: BHP, Provider, Staff and Admin Focus Groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1: Evaluation of Educational Materials
Educational Materials that have been developed related to using a trauma related mobile app will be evaluated by focus groups comprised of Patients and BHPs. The participants will be asked to use a think aloud approach using semi-structured interviews in order to determine the acceptability, usability and feasibility of the materials using questions developed to evaluate these items assessed during the focus group.
Measured: 5 months
Aim 2: Feasibility
Feasibility will be assessed using semi-structured interviews. BHPs, Clinical Staff, Providers, Administration and Patients will complete semi-structured interviews guided by the Integrated Promoting Action on Research Implementation in Health Services Framework.
Measured: 8 months
Aim 2: Acceptability: App Use
Acceptability will also be measured by the number of patients who have downloaded and used the app for the duration of the 6 week study time-frame.
Measured: 8 months
Aim 2:Usability
Patient usability of the app will be assessed using the 18-item mHealth App Usability Questionnaire (MAUQ). In this questionnaire each item is rated from 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree. Scale Max= 126. Scale Min= 18
To determine the usability of an app, calculate the total and determine the average of the responses to all of the 18 statements. The higher the overall average, the higher the usability of the app.
Measured: 8 months
Aim 2: Patient Burden
Patient acceptability, patients will complete the 20-item User Burden Scale at both follow-up visits. The scale has shown good overall inter-item reliability, convergent validity, and concurrent validity. The User Burden Scale (UBS) is a 20-item instrument used to assess perceived burden from digital health technologies across domains such as difficulty of use, time, physical demand, privacy, guilt, and financial burden. Each item is scored from 0 (Not at all) to 4 (Extremely), with total scores ranging from 0 (minimum) to 80 (Maximum). Higher scores indicate greater burden.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start3 Aug 2022
- Primary completion22 Mar 2024
- Study completion22 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaret R Emerson, DNP, APRN, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374408
- Sponsor's protocol ID
- 0178-21-EP
- Status last verified
- Jun 2025
- First submitted
- 3 May 2022
- Last updated
- 9 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou L, Bao J, Setiawan IMA, Saptono A, Parmanto B. The mHealth App Usability Questionnaire (MAUQ): Development and Validation Study. JMIR Mhealth Uhealth. 2019 Apr 11;7(4):e11500. doi: 10.2196/11500.
PubMed 30973342Elwyn G, Frosch D, Thomson R, Joseph-Williams N, Lloyd A, Kinnersley P, Cording E, Tomson D, Dodd C, Rollnick S, Edwards A, Barry M. Shared decision making: a model for clinical practice. J Gen Intern Med. 2012 Oct;27(10):1361-7. doi: 10.1007/s11606-012-2077-6. Epub 2012 May 23.
PubMed 22618581Stetler CB, Damschroder LJ, Helfrich CD, Hagedorn HJ. A Guide for applying a revised version of the PARIHS framework for implementation. Implement Sci. 2011 Aug 30;6:99. doi: 10.1186/1748-5908-6-99.
PubMed 21878092
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IDeA-CTR-Using Mobile Technology to Address the Trauma Mental Health Treatment Gap in Primary Care: Developing Implementation Protocols for Primary Care
- ClinicalTrials.gov ID
- NCT05374408
- Acronym / sponsor ID
- 0178-21-EP
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 16 May 2022 (actual)
- Results
- Posted 9 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BounceBack Now (BBN) is a self-help, trauma-focused mental health mobile application (app) with automated assessment with treatment guidance and in-app evidence-based treatment support for depression, post-traumatic stress disorder (PTSD), sleep difficulties, and anxiety. BBN contains many of the necessary components to promote self-management of these conditions. Investigators will evaluate the app's feasibility and acceptability among under served participants (e.g., African Americans and participants with lower socioeconomic status) with trauma histories in an integrated primary care (IPC) setting. There are two specific aims: 1) to develop educational materials for patients and behavioral health providers for BBN in IPC, and 2) to conduct a pilot trial of BBN for participants with trauma histories in an IPC setting. For Aim 1, focus groups with behavioral health providers and participants will be conducted to obtain feedback about BBN and training materials. For Aim 2, a feasibility study with 15 participants will be conducted to identify and address any procedural issues and to refine the protocol before conducting the full-scale study.
Detailed description
BounceBack Now (BBN) is a Trauma Focused Mobile Application. After consent, a behavioral health provider (BHP) will assist the participant in downloading BBN onto their smartphone device. The current BBN structure contains a brief assessment and multiple treatment components for disorders that are frequently associated with traumatic event exposure. A brief assessment based on the Kessler 6 will be completed and based on this assessment, the participants are then guided to treatment recommendations with an interactive rationale for each treatment. Education/explanations are provided in written, spoken, and animated video formats. Given that each of these treatments may be beneficial for patients with subsyndromal or very minor symptoms, all participants are able to see and interact with all treatment components, but it is anticipated that BHPs will provide recommendations for the sections that will be most beneficial. The treatment components are each based on effective in-person interventions. These include behavioral activation (depression), Written Exposure Therapy, and Expressive Writing (PTSD), Cognitive Behavioral Therapy for Sleep, and Relaxation/Mindfulness (stress/anxiety). The corresponding app sections are titled Activate, Write, Sleep, and Coping Tools, respectively. Each of these sections contains education components and there is a separate education component for the app overall that can be found through the coping tools page.
Aim 1: Develop educational materials for patients and Behavioral Health Providers (BHPs) for BBN in integrated primary care (IPC) settings. Investigators will present the educational materials and BBN in focus groups. These focus groups may be conducted virtually (i.e., zoom call) or in-person. The focus group will last 30 - 60 minutes. Focus groups will address acceptability, feasibility, and usability of the materials and the education materials and the app.
Focus groups will be audio recorded and a transcript will be prepared. Information obtained from the focus groups will be used to refine the patient and provider educational materials before we implement Aim 2 activities.
Aim 2: Conduct a pilot trial of BBN for participants with trauma histories in an IPC setting. A primary care provider at one of the two approved clinic locations will do a standard "warm handoff" referral to a behavioral health provider (BHP) if the patient is determined to have a behavioral health issue. The BHP will ask the patient about interest in participating the app study. If so, informed consent will be obtained and the participant screened using the Adverse Childhood Experience (ACE) screener to identify individuals at risk for trauma related conditions. Participants who screen positive on the ACE (>=3 points) will be invited to participate in further data collection for the study. A clinical assessment will be conducted, and a treatment assigned according to the standard of care specific to the mental health conditions of the participant. A brief explanation of BBN will be provided using the patient education material created under Aim 1. Certain features of the app will be suggested for use (e.g., journal, sleep intervention) according to participant need. The application is entirely self-paced, but a minimum use at least once a week is recommended.
Participants will complete a baseline survey online or through an investigational team member. Participants will continue to meet with their BHP as determined by the standard of care interactions, and, if deemed appropriate the BHP will highlight features contained in BBN for participant to use in between appointments. Follow-up phone calls will be scheduled for 2 week and 6 weeks after the initial visit to complete follow-up surveys, either online or administered by the investigative assistant over the phone. At the 6-week follow-up phone call, usability of the app will be assessed using the 18-item mHealth App Usability Questionnaire (MAUQ). Acceptability will be measured using the 20-item User Burden Scale. Additionally semi-structured interviews will be completed at that time or scheduled for an alternate date. The BHPs will complete a 5-item questionnaire about their comfort-level with integrating mental health apps into clinic care.
Addressing Needs of African American and Low-Income Patients:
The participating clinics primarily serve African American or low income patients. Race/ethnicity and income information will be collected through electronic health record data. The needs of these two patient population groups will be met by recruiting participants primarily from these two population groups for both aims to ensure their perspectives will be reflected in the patient education materials and by obtaining feedback through the individual interviews conducted at the end of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BounceBack Now (BBN) Participants Aim 1 | – | Behavioral: Aim 1 Participant Focus GroupsParticipants who are receiving care at one of the designated integrated care clinics. |
| BounceBack Now (BBN) Behavioral Health Provider Aim 1 | – | Behavioral: Aim 1 BHP Focus GroupsBehavioral Health Providers who serve as a BHP at one of the designated integrated care clinics. |
| BounceBack Now (BBN) Participants Aim 2 | – | Behavioral: Aim 2: BounceBack Now (BBN) for Trauma Informed Care Deployment, Behavioral: Aim 2 : Participant Focus GroupParticipants who are receiving care at a designated integrated care clinic |
| Bounce Back Now (BBN) Aim 2 BHPs, Clinical Staff, Providers, and Administration | – | Behavioral: Aim 2: BHP, Provider, Staff and Admin Focus GroupsClinical staff, Behavioral Health Providers, Providers, and Administration staff who can provide feedback pertaining to the factors that contribute to app deployment in an integrated care setting. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with a trauma related disorder and behavioral health providers (BHPs) which are Clinical staff, providers and administration
Key inclusion criteria (6 listed)
- 19 years and older
- 19 years and older
- Newly referred to a behavioral health provider at the Fontanelle or Midtown Clinic
- Own a smart phone
Key exclusion criteria (9 listed)
- 18 years and younger
- 18 years and younger
- Referred to a behavioral health provider in the past year
- Does not own a smart phone
- Score 2 points or lower on the Adverse Childhood Experience screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aim 2: BounceBack Now (BBN) for Trauma Informed Care DeploymentBrief explanation of BounceBack Now (BBN) will be provided. Participants will be directed to areas of the application that are congruent with treatment focus identified during their standard of care appointment. Participants will complete a baseline survey by either going online or being contacted by a member of the investigational team. The investigative assistant will contact all participants in 2-3 days to help the participant navigate the BBN and complete the baseline survey, if needed. The participant will continue to meet with their behavioral health provider (BHP) as determined by the standard of care interactions. BHP will highlight features contained in BBN for participant to use in between appointments. Follow-up phone calls will be scheduled for 2 weeks and 6 weeks after initial visit. During these phone- calls the participant will be contacted by a member of the investigational team to complete follow-up surveys. | Behavioural | BounceBack Now (BBN) Participants Aim 2 |
| Aim 1 Participant Focus GroupsAt the beginning of the focus group the patients will be asked to download BBN on their smartphone device with the assistance of the research team, if they have not already done so. A basic tutorial of the BBN and the developed educational materials will be conducted/reviewed with the participants. After the tutorial and education has been provided the participants will be asked to try some of major features of the app. Then, they will be asked to review the patient education materials. They will be asked to discuss strengths and weaknesses of the materials. They will be also asked whether there is any content missing from the education material. | Behavioural | BounceBack Now (BBN) Participants Aim 1 |
| Aim 1 BHP Focus GroupsAt the beginning of the focus group the BHPs will be asked to download BBN on their smartphone device with the assistance of the research team, if they have not already done so. A basic tutorial of the BBN and the developed educational materials will be conducted/reviewed with the BHPs. After the tutorial and education has been provided the participants will be asked to try some of major features of the app. Then, they will be asked to review the patient education materials. They will be asked to discuss strengths and weaknesses of the materials. They will be also asked whether there is any content missing from the education material. | Behavioural | BounceBack Now (BBN) Behavioral Health Provider Aim 1 |
| Aim 2: BHP, Provider, Staff and Admin Focus GroupsSemi-structured interviews will be conducted with BHPs, Clinical Staff, Providers and Administration They will ask questions to BHPs, Clinical Staff, Providers and Administration about feasibility, acceptability, and usability of BBN and overall clinical protocol. | Behavioural | Bounce Back Now (BBN) Aim 2 BHPs, Clinical Staff, Providers, and Administration |
| Aim 2 : Participant Focus GroupSemi-structured interviews will be conducted with Participants to assess the feasibility, acceptability, and usability of BBN. | Behavioural | BounceBack Now (BBN) Participants Aim 2 |
Primary outcome
Aim 1: Evaluation of Educational Materials
Time frame: 5 months
Educational Materials that have been developed related to using a trauma related mobile app will be evaluated by focus groups comprised of Patients and BHPs. The participants will be asked to use a think aloud approach using semi-structured interviews in order to determine the acceptability, usability and feasibility of the materials using questions developed to evaluate these items assessed during the focus group.
Aim 2: Feasibility
Time frame: 8 months
Feasibility will be assessed using semi-structured interviews. BHPs, Clinical Staff, Providers, Administration and Patients will complete semi-structured interviews guided by the Integrated Promoting Action on Research Implementation in Health Services Framework.
Aim 2: Acceptability: App Use
Time frame: 8 months
Acceptability will also be measured by the number of patients who have downloaded and used the app for the duration of the 6 week study time-frame.
Aim 2:Usability
Time frame: 8 months
Patient usability of the app will be assessed using the 18-item mHealth App Usability Questionnaire (MAUQ). In this questionnaire each item is rated from 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree. Scale Max= 126. Scale Min= 18 To determine the usability of an app, calculate the total and determine the average of the responses to all of the 18 statements. The higher the overall average, the higher the usability of the app.
Aim 2: Patient Burden
Time frame: 8 months
Patient acceptability, patients will complete the 20-item User Burden Scale at both follow-up visits. The scale has shown good overall inter-item reliability, convergent validity, and concurrent validity. The User Burden Scale (UBS) is a 20-item instrument used to assess perceived burden from digital health technologies across domains such as difficulty of use, time, physical demand, privacy, guilt, and financial burden. Each item is scored from 0 (Not at all) to 4 (Extremely), with total scores ranging from 0 (minimum) to 80 (Maximum). Higher scores indicate greater burden.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30973342Zhou L, Bao J, Setiawan IMA, Saptono A, Parmanto B. The mHealth App Usability Questionnaire (MAUQ): Development and Validation Study. JMIR Mhealth Uhealth. 2019 Apr 11;7(4):e11500. doi: 10.2196/11500.
- Background: PubMed 22618581Elwyn G, Frosch D, Thomson R, Joseph-Williams N, Lloyd A, Kinnersley P, Cording E, Tomson D, Dodd C, Rollnick S, Edwards A, Barry M. Shared decision making: a model for clinical practice. J Gen Intern Med. 2012 Oct;27(10):1361-7. doi: 10.1007/s11606-012-2077-6. Epub 2012 May 23.
- Background: PubMed 21878092Stetler CB, Damschroder LJ, Helfrich CD, Hagedorn HJ. A Guide for applying a revised version of the PARIHS framework for implementation. Implement Sci. 2011 Aug 30;6:99. doi: 10.1186/1748-5908-6-99.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret R Emerson, DNP, APRN principal investigator
University of Nebraska
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Traumatic Stress Disorder, run by University of Nebraska at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1: Evaluation of Educational Materials (time frame: 5 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05374408, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.